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Chapter 61 - Ch. 61: Judgment (1)

As the influence of the lobbying carried out by the major pharmaceutical corporations began to weaken,the FDA's document review process finally started.

At the very least, the review procedures were now officially underway.

There was, however, one major problem.

Unlike Korea's MFDS, it was impossible to keep the raw materials and manufacturing methods of new drugs confidential from the FDA.

Because of that, I had a long and serious discussion with CTO Kang Joo-tae.

"This is certainly your secret alone, CEO—something even I don't fully understand," Kang said."I'm referring to that white crystal added at the final stage of the manufacturing process."

"To be honest, even though I can produce it, I don't completely understand the exact principle behind how it works," I admitted."That's why, once the research organization you'll lead is fully established,I'd like you to analyze and study that white crystal in depth."

"I see. Truly innovative technologies are often like that," Kang replied."Still, what you're really asking is whether there's a way to deceive the FDA, correct?I agree—it feels extremely risky to hand over such an overwhelming technology directly to a U.S. government agency."

"Yes. Is there any possible way?"

"If we're going to mislead the FDA, we'll need a plan that's extremely meticulous and subtle," Kang said."For drugs approved in the U.S., they sometimes dispatch inspection teams without warning—even to overseas manufacturing facilities."

"So… it won't be easy?"

"It won't be. But fortunately, the white crystal used in Luktic's drug manufacturing is a substance that has never existed before.If we play this right, deceiving the FDA may not be impossible."

After thinking silently for a moment, Kang spoke again with a meaningful look.

"CEO, based on my observations, that white crystal appears to act as a catalyst during the manufacturing process. Is that correct?"

"Yes, that's right."

"The FDA's ingredient reviews usually focus on active pharmaceutical ingredients—the substances that actually enter the human body and produce therapeutic effects.If the white crystal is used only during manufacturing and does not remain in the final drug,their scrutiny of it will be significantly lighter."

"Then… does that mean we wouldn't need to submit the manufacturing method or composition of the white crystal?"

"That depends on the discretion of the examiner, but there's a very real chance," Kang replied."Like most things, it ultimately depends on the skill and judgment of the official in charge."

Kang continued after checking several documents on his computer.

"In that case, the key will be carefully obscuring the true identity of the white crystal.Based on your experience, can we say with certainty that the finished drug contains none of its components?"

After countless experiments and production runs,the weight and volume of the Luktic base catalyst stone had never decreased.

In other words, it functioned as a pure catalyst.It was safe to say that the final drug contained none of its substance.

"Yes. It's only used as a catalyst during manufacturing.None of it remains in the finished product."

"Excellent. Then we'll assign the white crystal a designation—a complex code made of letters and numbers—and define it as a proprietary Luktic material used solely as a manufacturing catalyst.And we'll need to prove that none of it is present in the final drug."

"So when FDA inspectors visit, we can show them that the crystal's weight is unchanged before and after production."

"Exactly.If we use this approach correctly, we can secure approval without disclosing the crystal's composition or manufacturing method."

We decided to name the white crystal—the Luktic Base Catalyst Stone—RUQ-099.We then organized all related documentation and delivered it to Target.

***

Carter sat alone in a corner of a park, staring blankly ahead.

It had been two months since his father's condition had rapidly worsened.

And yesterday morning, his father had passed away.

After being rushed to the hospital late that night,his father never regained consciousness.

He had remained in a deep coma, sustained only by life-support equipmentand large doses of narcotic painkillers.

The doctor had said:

Perhaps it was fortunate that he was able to pass peacefully.

Carter agreed with that assessment.

Terminal cancer patients often spent their final monthswrithing in unbearable pain.

In comparison, his father's end had been relatively calm.

But one thought refused to leave Carter's mind.

If Elixir had existed…my father might have recovered.

Just two months ago,the atmosphere within the pancreatic cancer family support grouphad been filled with hope.

Given Elixir's effectiveness,many believed the FDA might grant fast-track approval.

Yet for some reason, the process dragged on.

Only now—after two long months—had the FDA finally begun document review.

Carter knew why.

He knew that the existing pharmaceutical industryhad been doing everything in its powerto delay and obstruct approval of Luktic's drugs.

That topic dominated cancer patient communities online.

Even then, Carter had felt frustrated and angry—but he had still believed in the FDA.

He trusted that the agency would ultimately actfor citizens like him and his father,whose lives depended on time.

That trust had been shattered.

Not only had fast-track approval failed to materialize,but even basic document reviewhad begun only after his father's death.

To Carter, his father had been a pillar of the world.

After his parents' divorce,his father had raised him alone.

They were never wealthy,but Carter grew up surrounded by love,earned scholarships, graduated from a state university,and secured a respectable job.

Just as he was finally ready to give his father a comfortable life,the diagnosis came—pancreatic cancer.

And it wasn't just his father.

Every terminal cancer patient in the same ward had passed away, one by one.The same was true for patients cared for by families in the same support group.

One thought haunted Carter relentlessly.

If Elixir had been available, many of them could have lived.

He had read that after Elixir's approval,Korea's mortality rate from severe illnesseshad dropped by 78%.

After learning that, Carter could no longer forgivethe pharmaceutical companies that had deliberately delayed approvaland pushed countless patients toward death.

He began investigating the core force behind the lobbying effortblocking Elixir's approval—the National Pharmaceutical Alliance.

After combing through press releases all night,he discovered that the alliance's centerappeared to be WhiteLily,one of the world's top three pharmaceutical corporations.

From the beginning, WhiteLily had gathered global Big Pharmaand formed the alliance.

Carter glared at the image of Chairman Whitedisplayed on his computer screen,his eyes burning with hatred.

***

I received a call from the MFDS.

They said the approval process for the hair-loss treatmentas a modified new drug was progressing smoothlyand had entered its final stage.

At the latest, sales approval should be granted within one week.

Not long ago, at the request of the MFDS Vice Minister,I had also applied the hair-loss treatmentto the MFDS Commissioner himself.

The next day, he called me directly,his voice filled with emotion,and promised to do everything in his powerto ensure rapid approval.

There was no doubt—the effect of the hair-loss treatment was extraordinary.

Dong-sik, who had come to headquarters after a long time, said to me,

"Si-woo, I hear the hair-loss treatment is about to be approved.Looks like Luktic is really becoming a world-class corporation."

"Yeah.It feels like just yesterday we were starting out in that tiny warehouse,and now things have grown this big. Haha."

"It was all possible because you developed those insane technologies.Thanks to you, I get to live comfortably as an executive at a company with a bright future.Thanks, Si-woo. Truly."

"Don't say things like that.I got plenty of help from you in the early days too."

He chuckled.

"Seriously, our CEO is way too kind.But I heard approval in the U.S. keeps getting delayed because existing pharma companies are interfering?"

"That's right.Things have improved a bit since FDA review finally started,but after what Shinjeon Group pulled here in Korea…it's all pretty disgusting."

"It really is.If Elixir were available, countless patients could be saved right now—but people are dying because approval is being delayed.Honestly, it makes me angry."

He was right.

Delays in U.S. approval weren't just hurting Luktic's market entry—they meant people who could livewere still dying.

If I were in the same position—if my father were terminaland a life-saving drug existed overseas but approval was delayed at home—

I would be utterly desperate.

More than profit,I wanted Elixir approved as quickly as possibleso that patients around the worldcould gain a chance at survival.

***

Chairman White of WhiteLilywas chatting lightly with his directors in the boardroom.

"We've managed to delay things to some extent.We need to keep buying time—no matter what.During that time, we must uncover how Luktic created such extraordinary drugs."

"Yes, Chairman.All of our research teams are fully focused on analyzing Luktic's technology.We're also planning various methods to extract internal information."

"Excellent.Other pharmaceutical companies are likely doing the same.WhiteLily must be the first to seize that secret."

White smiled confidently.

In the end, R&D was a race against time.

If they continued delaying approval while analyzing Luktic's technology,a breakthrough would eventually come.

Then one director hesitantly spoke up.

"Chairman… are we really okay doing this?If Elixir were imported, countless patients could be saved.Deliberately delaying approval… isn't that—"

White cut him off.

"Murder?"

The director froze.

"I-I didn't mean it that way…"

White waved it off.

"My dear Director Pence, you're far too soft-hearted.Relax. We didn't ban Elixir outright—we're only delaying approval in the U.S. and Europe."

"…."

"If someone truly wants treatment,they can go to Korea, where Elixir is already approved.How is that murder?There's a choice, isn't there?"

Most people, of course, couldn't afford treatment abroad—and many severe patients couldn't even board a plane.

But such facts meant nothing to White.

He walked over and patted Pence on the shoulder.

"Don't get weak.We need to protect our positions.If we fail to stop Luktic here,we'll all be fired at the next shareholders' meeting."

"Yes, Chairman…"

"Alright. I have an external appointment.Carry on with your work."

White left the building with his entourage.

As he stepped out the rear entrance,a man approached from the alley beyond.

Something about the man felt wrong—ominous, heavy.

White felt an instinctive chill.

"W-Who is that…? Security—!"

But the man was already within ten meters.

He pulled back his hood and stared at White.

In a low voice, he spoke.

"I've come to judge the demonwho sent countless patients to their deathsfor the sake of petty profit."

The man raised his hand.

In it was a black handgun.

"Guards! Guards!"

White crouched and screamed.

Two bodyguards rushed out from the black limousine nearby.

But it was already too late.

The gun was aimed squarely at White.

And the man pulled the trigger.

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